Montelukast Sodium

Product NDC
55111-763
11-digit product format
551110763
Labeler code
55111
Product ID
55111-763_1d9ac31e-956b-897f-2d41-da76d70dd40c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
GRANULE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA202906
Marketing category
ANDA
Marketing start
2012-09-20
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
4 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55111-763IInactivated by FDA2026-10-15
excluded packagepackage55111-76355111-763-03IInactivated by FDA2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55111-763-03IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55111-763-03IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55111-763-03IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55111-763-03IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55111-763-03IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55111-763-03IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55111-763-03UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55111-763-03UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55111-763-03UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202906-001MONTELUKAST SODIUMMONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202906-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17c2088c7a36db…
2026-09-14 22:38:342026-08A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-1784e616aacf4f…
2026-08-18 06:07:402026-07A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-173f01610625f2…
2019-09-15 20:21 UTC2019-09A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202906-001MONTELUKAST SODIUMEQ 4MG BASE/PACKETGRANULE / ORALAB2012-09-173a93d1ddd44b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A202906-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A202906-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A202906-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202906-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202906-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202906-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202906-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202906-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202906-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202906-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202906-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202906-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202906-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202906-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202906-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202906-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202906-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202906-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202906-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202906-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202906-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202906-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202906-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202906-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202906-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202906-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202906-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202906-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202906-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202906-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202906-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202906-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202906-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202906-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202906-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202906-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202906-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202906-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202906-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202906-001AB13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-763-03Montelukast Sodium30 in 1 CARTONGRANULE3015
55111-763-07Montelukast Sodium500 in 1 PACKETGRANULE50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-763-03EA - Each55111-763569ceb14-5889-4aeb-804d-5c1cac519e0412013-02-13
55111-763-07EA - Each55111-763ef749b31-25f5-4d9c-a7e2-3dadf931d5bf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12
montelukastACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82MONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-763MONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]15Legacy NDC, 2 package rows20190920_3d3df874-d710-7fa4-bb21-434977518337.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351246montelukast sodium 4 MG Oral GranulesPSN3d3df874-d710-7fa4-bb21-43497751833715
351246montelukast 4 MG Oral GranulesSCD3d3df874-d710-7fa4-bb21-43497751833715
351246montelukast 4 MG (as montelukast sodium 4.2 MG) Oral GranulesSY3d3df874-d710-7fa4-bb21-43497751833715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-763-035511107630330 PACKET in 1 CARTON (55111-763-03) > 500 GRANULE in 1 PACKET (55111-763-07) 30 packet2012-09-200000-00-00NoNoCurrent
55111-763-0755111076307500 in 1 PACKETHistorical